Cleared Special

K100400 - PRESTODR PORTABLE

K100400 is an FDA 510(k) clearance for PRESTODR PORTABLE, manufactured by Cmt Medical Technologies, Ltd.. The device is a Class 2 Radiology device with product code IZL cleared through the Special 510(k) pathway after a 65-day FDA review.

K100400 · Cmt Medical Technologies, Ltd. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2010
Decision
65d
Days
Class 2
Risk

K100400 is an FDA 510(k) clearance for the PRESTODR PORTABLE. Classified as System, X-ray, Mobile (product code IZL), Class II - Special Controls.

Submitted by Cmt Medical Technologies, Ltd. (Yoqneam Ilit, IL). The FDA issued a Cleared decision on April 22, 2010 after a review of 65 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1720 - the FDA radiology and imaging software oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K100400

510(k) Number K100400 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 16, 2010
Decision Date April 22, 2010
Days to Decision 65 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
42d faster than avg
Panel avg: 107d · This submission: 65d
Pathway characteristics
Modification to existing cleared device.

IZL Device Classification - Class 2, Special Controls

Product Code IZL System, X-ray, Mobile
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1720
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - IZL System, X-ray, Mobile

All 236
Devices cleared under the same product code (IZL) and FDA review panel - the closest regulatory comparables to K100400.
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K100400 · PRESTODR PORTABLE
Download PDF FDA Summary Cmt Medical Technolog…